Medication info

Union Ambroxol Injection (Ambroxol Hydrochloride)

Prescription medication정맥
Ingredient · strength
Ambroxol Hydrochloride›7.5mg / 1mL
Manufacturer / importer
한국유니온제약(주)
Appearance
Brown ampoule filled with a colorless liquid
Packaging
For domestic use - 2 milliliters/ampoule [2mL x 100 ampoules], for export - 2 milliliters/ampoule [2mL x 10 ampoules]
Approval status
Active

MFDS item code 200101403 · Notified 2001.08.06 · Insurance code 665503021

Summary

Main use
Efficacy in preventing respiratory diseases (chronic bronchitis, asthma) and promoting the production of pulmonary surfactant.
Who receives it
Adults · Children
Adult administration
As ambroxol hydrochloride, administer 15 mg per dose for intravenous injection 2 to 3 times a day slowly. In severe cases, it can be increased to 30 mg per dose, infused slowly with normal saline or Ringer's solution.
Child administration
Ages 5 and above: 15 mg per dose for intravenous injection 2 to 3 times a day. Ages 2 to 4: 7.5 mg per dose for intravenous injection 3 times a day. Under 2 years: 7.5 mg per dose for intravenous injection 2 times a day. Pediatric:

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Efficacy in preventing respiratory diseases (chronic bronchitis, asthma) and promoting the production of pulmonary surfactant.

  • Mucus secretion disorders
  • acute bronchitis
  • chronic bronchitis
  • asthmatic bronchitis
  • acute episodes of bronchial asthma
  • respiratory distress syndrome
  • chronic obstructive pulmonary disease
  • pulmonary complications.
View approved original text

This medication is used to treat acute episodes of chronic bronchitis, asthmatic bronchitis, and bronchial asthma caused by mucus secretion disorders. It also helps facilitate the production of pulmonary surfactant in newborns and premature infants suffering from respiratory distress syndrome. Additionally, it is effective in preventing pulmonary complications before and after surgery in patients with chronic obstructive pulmonary disease. Overall, this medication is used for the treatment and prevention of various respiratory diseases.

How it is given

Adult administration

As ambroxol hydrochloride, administer 15 mg per dose for intravenous injection 2 to 3 times a day slowly. In severe cases, it can be increased to 30 mg per dose, infused slowly with normal saline or Ringer's solution.

Child administration

Ages 5 and above: 15 mg per dose for intravenous injection 2 to 3 times a day. Ages 2 to 4: 7.5 mg per dose for intravenous injection 3 times a day. Under 2 years: 7.5 mg per dose for intravenous injection 2 times a day. Pediatric:

Precautions

This medication should be opened carefully when using a glass ampoule, as glass fragments may mix in, especially when administering to children or the elderly. It should not be used in patients with allergic reactions to this drug or any of its components. Caution is required when administering to patients with poor kidney function or severely impaired liver function, as well as to children under 2 years of age. Serious skin conditions may occur rarely with this medication, so if any abnormalities on the skin or mucous membranes arise, use should be discontinued immediately and appropriate treatment sought. Gastrointestinal discomfort, nausea, vomiting, heartburn, dry mouth, abdominal discomfort, stomach or abdominal bloating, stomach pain, diarrhea, constipation, loss of appetite, skin rash, urticaria-like erythema, itching, facial swelling, fever accompanied by chills, purulent rhinitis with increased white blood cell count, sensory disturbances of the tongue, taste changes, oral paralysis symptoms, arm numbness, headache, leg pain, and extreme fatigue may occur. Rarely, skin rashes or severe allergic reactions may arise, and if symptoms such as facial swelling, difficulty breathing, or hives develop, medical personnel should be notified immediately. Inflammation of the respiratory tract may occur, and rare neurological symptoms such as changes in tongue sensation or taste, arm numbness have been reported. When used with antibiotics, increased secretion in the bronchi or lungs may heighten antibiotic concentration, so caution is advised. Use during pregnancy, especially in the first trimester, is not recommended, and if nursing, it should be used cautiously after consultation with a doctor, as this medication can be transmitted through breast milk. Elderly patients may have decreased bodily function, necessitating a reduction in dosage or careful monitoring during use. No unusual symptoms have been reported in cases of overdose, but if abnormal symptoms occur, immediate consultation with healthcare professionals and symptomatic treatment should be sought. When injecting, headache, leg pain, and extreme fatigue may occur, therefore slow injection is advisable. This medication can only be mixed with normal saline injection or Ringer's solution for intravenous infusion and should be used within 24 hours of mixing. Keep this medication out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • difficulty breathing
  • severe acute anaphylactic reactions
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis.

Mild side effects

Indigestion, nausea, vomiting, heartburn, dry mouth, discomfort in the stomach, stomach and abdominal bloating, stomach pain, diarrhea, constipation, loss of appetite, skin rash, urticaria-like erythema, itching, facial swelling, fever accompanied by chills, purulent rhinitis with increased white blood cell count, sensory disturbances of the tongue, taste changes, oral numbness, arm numbness, headache, leg pain, extreme fatigue.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light exposure. It is best stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Brown ampoule filled with a colorless liquid

Package unit

For domestic use - 2 milliliters/ampoule [2mL x 100 ampoules], for export - 2 milliliters/ampoule [2mL x 10 ampoules]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.